UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008437
Receipt No. R000009925
Scientific Title The effect of lallidinogenase for the postoperative retina thickness and visual acuity etc.in diabetic macula edema.
Date of disclosure of the study information 2012/07/14
Last modified on 2018/07/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of lallidinogenase for the postoperative retina thickness and visual acuity etc.in diabetic macula edema.
Acronym The effect of kallidinogenase for postoperative diabetic macula edema.
Scientific Title The effect of lallidinogenase for the postoperative retina thickness and visual acuity etc.in diabetic macula edema.
Scientific Title:Acronym The effect of kallidinogenase for postoperative diabetic macula edema.
Region
Japan

Condition
Condition Diabetic macula edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of kallidinogenase for postoperative in diabetic macula edema
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Foveal retinal thickness
Key secondary outcomes Visual acuity,fundus findings,recurrence of the edema,number of the exaples of aan ophthalmic treatment addition,number of the times of an addition,and period to an addition,the safety assessment(rate of adverse events)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Kallidinogenase(+)oral
Interventions/Control_2 Kallidinogenase(-)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients underwent vitrectomy for diabetic macula edema,who met the all inclusion criteria.
(a)Older than 20tears of age at the time of the acquisition agreement.
(b)Allowed to go to the Hiroshima University Hospital regularly for one year.
(c)Obtained consentin written foem of the study participants.
Key exclusion criteria (a)Sever side effects by the past kallidinogenase preparations.
(b)Treated by kallidinogenase within one month of preparation before the start of this drug.
(c)HbA1c 10%.
(d)Treated with steroids or anti-VEGF drugs(drugs contraindicated in combination)
(e)Pregnant and lactating woman or woman who may become pregnant.
(f)Any others judged by the doctor in charge to be ineligible for subjects in the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Hiroshima University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Kasumi1-2-3,Minami-ku,Hiroshima
TEL 082-257-1576
Email z.ohhara@tsukazaki-eye.net

Public contact
Name of contact person
1st name
Middle name
Last name Zaigen Ohara
Organization Saneikai Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address 68-1,Aboshiku waku,Himeji city,Hyougo Prefecture
TEL 079-272-8555
Homepage URL
Email z.ohhara@tsukazaki-eye.net

Sponsor
Institute Department of Ophthalmology,Hirosima University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology,Hirosima University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Saneikai Tsukazaki Hospital Ophthalmology
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 14 Day
Last modified on
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.